Chlordiazepoxide Hydrochloride
C16H14ClN3O·HCl
336.22
336.223H-1,4-Benzodiazepin-2-amine, 7-chloro-N-methyl-5-phenyl-, 4-oxide, monohydrochloride.
7-Chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide monohydrochloride
[438-41-5].» Chlordiazepoxide Hydrochloride contains not less than 98.0 percent and not more than 102.0 percent of C16H14ClN3O·HCl, calculated on the dried basis.
Packaging and storage—
Preserve in tight, light-resistant containers.
Labeling—
Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards 
11
—
USP 2-Amino-5-chlorobenzophenone RS.
USP Chlordiazepoxide Hydrochloride RS.
USP Chlordiazepoxide Related Compound A RS.
USP Endotoxin RS.
11—
USP 2-Amino-5-chlorobenzophenone RS.
USP Chlordiazepoxide Hydrochloride RS.
USP Chlordiazepoxide Related Compound A RS.
USP Endotoxin RS.
Identification—
B:
The relative retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
C:
To about 20 mg add 5 mL of hydrochloric acid and 10 mL of water, and heat to boiling to effect hydrolysis. To the cooled solution add 2 mL of sodium nitrite solution (1 in 1000), 1 mL of ammonium sulfamate solution (1 in 200), and 1 mL of N-(1-naphthyl)ethylenediamine dihydrochloride solution (1 in 1000): a reddish violet color is produced.
Loss on drying 731—
Dry it in vacuum over phosphorus pentoxide at 60
for 4 hours: it loses not more than 0.5% of its weight.
731—
Dry it in vacuum over phosphorus pentoxide at 60 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281:
not more than 0.1%.
281:
not more than 0.1%.
Heavy metals, Method II 231:
0.002%.
231:
0.002%.
Related compounds—
It meets the requirements of the test for Related compounds under Chlordiazepoxide.
Other requirements—
Where the label states that Chlordiazepoxide Hydrochloride is sterile, it meets the requirements for Sterility Tests 71 and Labeling under Injections 1, and Bacterial endotoxins under Chlordiazepoxide Hydrochloride for Injection. Where the label states that Chlordiazepoxide Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Chlordiazepoxide Hydrochloride for Injection.
71 and Labeling under Injections 1, and Bacterial endotoxins under Chlordiazepoxide Hydrochloride for Injection. Where the label states that Chlordiazepoxide Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Chlordiazepoxide Hydrochloride for Injection.
Assay—
[note—Use low-actinic glassware in this procedure.] Proceed as directed in the Assay under Chlordiazepoxide, except to use USP Chlordiazepoxide Hydrochloride RS when preparing the Standard preparation.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Ravi Ravichandran, Ph.D.
Senior Scientist 1-301-816-8330 |
(MDPP05) Monograph Development-Psychiatrics and Psychoactives |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 1896
Pharmacopeial Forum: Volume No. 29(6) Page 1859
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.